Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 23, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT00553410). This is a study registration, not published results. Lead sponsor: ETOP IBCSG Partners Foundation. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 4884 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: Letrozole; DRUG: Letrozole. Primary outcome measures: Disease-free Survival (DFS) , 5-year estimates, reported at a median follow-up of 60 months. Brief summary: RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.